Deciphering the Role of Oxytocin in Motivation: an fMRI Study

What Was Tested

The trial (phase 2) is built around Oxytocin.

It had two arms (groups): Placebo (placebo comparator) and Oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

Oxytocin is hypothesized to facilitate social behaviors via its modulation of motivational networks.

With this study, the researchers will characterize oxytocin's effects on the neural processing of salient stimuli.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to men only aged from 20 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 20-35 years of age at the time of screening. No current or past history of neurological or psychiatric illness, including substance abuse or dependence. No acute medical illness. Written informed consent obtained from subject.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: left-handedness or ambidextrous; known allergies to oxytocin or to preservatives in the nasal spray; any current or past history of medical, neurological, or psychiatric illness or family history of psychiatric or neurologic disease in first-degree relatives.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2012-10 with completion listed for 2013-09.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment (time frame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1)).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.